Chronic Kidney Disease Clinical Trial
Official title:
The Quantitative Ultrasound Assessment of Lean and Intramuscular Adipose Tissue in Veterans With Chronic Kidney Disease
Currently there is no standard way to detect age-related skeletal muscle loss in patients with chronic kidney disease. Investigators are working on finding rapid and inexpensive ways to measure muscle size and fat within the muscle.
The accelerated muscle wasting associated with chronic kidney disease (CKD) is a source of
morbidity and an increased incidence of bone fracture secondary to falls. However, sarcopenia
secondary to CKD is not routinely screened or assessed in this patient population. This
protocol, "Quantitative Ultrasound Assessment of Lean and Intramuscular Adipose Tissue in
Veterans Project" (i.e., QUALITY VETS) is a VA Center for Innovation (VACI) funded pilot
study with the purpose of using a clinically viable sarcopenia screening approach for
Veterans with CKD who are currently receiving care at the Renal Service.
The investigative team will screen and assess diminished muscle mass, quality, and
performance in Veterans with CKD (Stage 3 and 4), and also examine the relationship between
the muscle characteristics and estimated fall risk within the sample. Key outcome measures
will be obtained within the domains of muscle performance (peak grip strength), functional
status (Short Physical Performance Battery), estimates of tissue/body composition (diagnostic
ultrasound and DXA), and fall risk (Timed Up-and-Go test). Secondary measures will include
questionnaires regarding of fall avoidance, physical activity, depression, and quality of
life (QoL).
The general analysis approach will be to characterize the proportion of participants with:
sarcopenia based on the European Working Group on Sarcopenia in Older People (EWGSOP)
algorithm, low muscle quality based on preliminary echogenicity cut off values and criterion
strength values, and an elevated risk of falling based on the Timed Up-and-Go age-dependent
cut off values. Investigators will determine the magnitude of association between the
skeletal muscle outcomes and fall risk within the participant sample. Hazard ratios will be
used to estimate the impact of the sarcopenia classification and echogenicity values on the
positive classification of fall risk.
The optimal treatment of Veterans with CKD who have an elevated risk of falls may be enhanced
by the timely identification of accelerated muscle changes. The QUALITY-VETS Project will
help to determine appropriate screening and assessment strategies that could be implemented
in subsequent longitudinal studies involving exercise interventions and fall prevention
training.
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